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Evaluation of Total Analytical Error for Quantitative Medical Laboratory Measurement Procedures, 2nd Edition

This guideline provides manufacturers and end users with an understanding of concepts related to total analytical error (TAE) for quantitative measurement procedures. An experimental protocol and data analysis method are provided to estimate TAE based upon a comparison of methods experiment with patient specimens, and to assess it relative to a pre-established goal for clinical acceptability.

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Chairholder: J. Rex Astles, PhD, FACB, DABCC

Date of Publication: July 1, 2016

Order Code PDF: CLSI EP21Ed2E
ISBN Number: 1-56238-941-6

Order Code Print: CLSI EP21Ed2
ISBN Number: 1-56238-940-8

Edition: Second

Pages: 68

CLSI EP21 Additional Details

The U.S. Food and Drug Administration (FDA) has evaluated and recognized this approved-level consensus standard for use in satisfying a regulatory requirement.

CLSI EP21 Abstract

Clinical and Laboratory Standards Institute guideline EP21—Evaluation of Total Analytical Error for Quantitative Medical Laboratory Measurement Procedures provides manufacturers and end users with a means to estimate total analytical error (TAE) for a quantitative measurement procedure and to assess if it meets pre-established specifications. Error is defined in terms of observed bias, using patient specimens tested with either a reference or comparative measurement procedure as described in CLSI document EP09.1 This assessment incorporates multiple analytical error sources, including imprecision, bias, nonlinearity, interferences, specimen-to-specimen matrix differences, and others. EP21 can be used to judge acceptability of candidate measurement procedures relative to performance goals reflective of clinical utility.